Strongest Families Ontario (Formerly the Family Help Program) (SF-ON)

September 1, 2016 updated by: IWK Health Centre

Delivering Intervention for Pediatric Behaviour Problems at a Distance: a Randomized Trial of Strongest Families Ontario

Strongest Families (formerly Family Help)is an evidence-based, distance health education model for families who have children with behavioural difficulties. The principal research question is "Does Strongest Families, a 12-week, home-based program of interactive readings, instructional videos, homework projects, and weekly "coaching" telephone calls out perform the care families typically experience when referred to a mental health service?". The investigators hypothesize that children randomized to Strongest Families intervention will show a significantly greater reduction in externalizing behaviour problems than those randomized to a Control (usual care). In addition, parents randomized to Family Help will report a greater improvement in parenting skills and a greater reduction in symptoms of emotional distress (i.e., feeling of anxiety, depression, and stress) than parents in the Control condition. Finally, families randomized to Family Help will use fewer mental health services than Controls.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Our project is designed to help families and children with mild or moderate symptoms early, before problems become worse and more difficult to treat.

The Strongest Families Program is a distance parenting program that was developed at the Centre for Research in Family Health at the IWK Health Centre in Halifax, Nova Scotia. Most families are able to manage these problems if they are given the skills to do so. The Strongest Families "Parenting the Active Child" Distance Program is done over the telephone; families do not have to travel to a centre to receive help. This program includes a handbook, videos and weekly phone calls between the parent and non-professional'coach'. The coach provides support to families, answer questions and guide parents as they learn the skills. Strongest Families has helped hundreds of families in Nova Scotia.

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3J 3G9
        • IWK Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Male or female individuals who meet all the following criteria are eligible for this trial:

  • Child is aged 6 to 12 years and
  • Completed and signed referral form from a participating intake site is received and
  • Parent/legal guardian provides verbal, telephone consent to participate and
  • Ability of participant to read and understand English (at a Grade 5 level) and
  • There must be the reasonable intention that for the study duration the child will remain in the direct care of the participant and at the same address as the participant (2 years) and o Child presents with significant levels of disruptive behaviour based on the BCFPI results at the referring agent end and clinical evaluation of the corroborative study assessment measures.

Exclusion Criteria:

Participants meeting one or more of the following criteria cannot be selected:

  • Child is in the care of a child protective agency or currently being investigated by a child protective agency
  • Child has received any form of behavioural treatment in the past 6 months
  • Child is at an imminent risk of harm to themselves or others
  • In the judgment of the investigator or delegate, any condition that may interfere with effective delivery of the study protocol/intervention program (i.e., High parental DASS-21 score, complex child symptomology, families who are unmotivated or are in complete chaos)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Strongest Families Program + Usual care
50% randomized to receive Strongest Families intervention immediately as well as the usual care services available via the referring agency for the 22 month study period.
Behavioral: Strongest Families Intervention (formerly Family Help)
Distance HEALTH education intervention focussed on skill learning for parents
Other Names:
  • formerly the Family Help Program
No Intervention: Usual care
50% randomized will not receive Strongest Families Intervention during the 22 month study phase, but will receive the usual care services available via the referring agency. At the end of the 22 month study period study participants will be offered the Strongest Families Intervention services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child Behaviour Checklist
Time Frame: Baseline, 5, 10, 16, 22 months
Results will be analyzed as change from baseline over time
Baseline, 5, 10, 16, 22 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alabama Parenting questionnaire
Time Frame: Baseline, 5, 10, 16, 22 months
Results will be analyzed as change from baseline over time
Baseline, 5, 10, 16, 22 months
SCAPI (economic)
Time Frame: Baseline,5, 10, 16, 22
Results will be analyzed as change from baseline over time
Baseline,5, 10, 16, 22
DASS-21
Time Frame: Baseline,5, 10, 16, 22
Results will be analyzed as change from baseline over time
Baseline,5, 10, 16, 22
Investigator designed Satisfaction measure
Time Frame: end of intervention
Participant satisfaction with this psychological intervention will be measured at the end of intervention that varies between participants, but on average is about 5 months post-randomization
end of intervention
Investigator designed disability measure
Time Frame: weekly during intervention
Results will be analyzed as change from baseline over time
weekly during intervention
Discrete Conjoint Preference survey: Investigator designed
Time Frame: baseline, 5, 16 months
We will examine if discrete choice data collected at baseline predicts participation, adherence and outcome. We will also explore changes in preferences over time.
baseline, 5, 16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IWK Health Centre

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Patrick J McGrath, PhD, Vice President of REsearch Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 22, 2011

First Submitted That Met QC Criteria

November 14, 2011

First Posted (Estimate)

November 17, 2011

Study Record Updates

Last Update Posted (Estimate)

September 2, 2016

Last Update Submitted That Met QC Criteria

September 1, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4839
  • MCT-91030 (Other Grant/Funding Number: Canadian Institutes of Health Research)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Aggregate summary data would be made available but not individual data.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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